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Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility

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ClinicalTrials.gov Identifier: NCT03549741
Recruitment Status : Unknown
Verified May 2018 by Ahmed Abdeltawab Mhanny, Assiut University.
Recruitment status was:  Not yet recruiting
First Posted : June 8, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
Ahmed Abdeltawab Mhanny, Assiut University

Study Description
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Brief Summary:
Infertility refers to an inability to conceive after having regular unprotected sex. Infertility can also refer to the biological inability of an individual to contribute to conception, or to a female who cannot carry a pregnancy to full term. In many countries infertility refers to a couple that has failed to conceive after 12 months of regular sexual intercourse

Condition or disease Intervention/treatment Phase
Infertility Drug: Clomiphene Citrate 50mg Drug: Cabergoline Oral Tablet Drug: Placebo Oral Tablet Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Cabergoline As An Adjuvant To Clomiphene Citrate For Management Of Unexplained Infertility: Randomized Controlled Trial
Estimated Study Start Date : July 2018
Estimated Primary Completion Date : June 2019
Estimated Study Completion Date : November 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Infertility

Arms and Interventions
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Arm Intervention/treatment
Experimental: study group
will receive a dose of Clomiphene citrate 50 mg tablet , 1 tab twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package) first three months then Clomiphene citrate 50 mg tablet , 2 tabs twice daily for 5 days from the third day of menses to the seven day and cabergoline 0.25 mg (half tablet) every 3 days (one package)
 Drug: Clomiphene Citrate 50mg
oral tablets

Drug: Cabergoline Oral Tablet
oral tablets
Active Comparator: control group
will receive a dose of Clomiphene citrate and placebo tablets with same dose and duration
 Drug: Clomiphene Citrate 50mg
oral tablets

Drug: Placebo Oral Tablet
oral tablets


Outcome Measures
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Primary Outcome Measures :
  1. The number of mature follicles [ Time Frame: 14 days ]
    the follicles reach the size of 18 mm


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • unexplained infertility, Primary or secondary.
  • Absence of galactorrhoea.
  • Normal serum prolactin.
  • Normal hysterosalpingography.
  • Normal spermogram.

Exclusion Criteria:

  • Women on other line of treatment as aromatase inhibitors,gonadotrophins, or tamoxifen.
  • Known hypersensitivity for cabergoline or clomiphene citrate.
  • Other factors of infertility as tubal factor, uterine factor or male factor.
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Ahmed Abdeltawab Mhanny, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03549741    
Other Study ID Numbers: CabCC
First Posted: June 8, 2018    Key Record Dates
Last Update Posted: June 8, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Infertility
Cabergoline
Clomiphene
Enclomiphene
Zuclomiphene
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
 Fertility Agents, Female
Fertility Agents
Reproductive Control Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agonists
Dopamine Agents
Neurotransmitter Agents